This is an accessory to Intelect Advanced — Class II medical device recall Z-2590-2020
Terminated recall by DJO, LLC, reported 2020-07-22, distributed nationwide. The device accessories were not labeled with appropriate latex warning.
| Recall number | Z-2590-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DJO, LLC, Vista, CA, United States |
| Recall initiated | 2018-06-25 |
| Classified | 2020-07-13 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2022-11-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, ID, IE, IL, IN, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LT, LU, MA, MT, MX, MY, NL, NO, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, TH, TN, TR, TT, TW, UA, VN, ZA |
| Quantity | 41,801 units |
| Reason classes | labeling |
Product
This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.
Reason for recall
The device accessories were not labeled with appropriate latex warning.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2590-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.